Titrated Versus High and Low Dose Nebulized Morphine to Reduce Pain in Emergency Settings (TIMORNEB)

University of Monastir

Status: Completed

Conditions: Post-Traumatic Headache; Acute Pain

Treatments: Drug: High dose nebulised morphine; Drug: Low dose nebulised morphine; Drug: IV titrated morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02200185

TIMORNEB

Details and patient eligibility

About

The investigators test a different technique using morphine to improve pain relief in patient visiting the emergency department with acute trauma pain, for this we are comparing three different methods of morphine administration:

• intravenous titrated morphine
• low dose nebulized morphine and
• high dose nebulized morphine

Full description

Trauma patients are frequent in emergency department settings, and often require urgent care.

taking care of this patients consists on taking care of their pain and then the specific treatment of their traumatic lesions.

actually, the most used medicine and most efficient one in treating pain is morphine, it's mechanism of action is by acting on receptors located on neuronal cell membranes and inhibit neurotransmitter release.

The most applied administration root of morphine is by intravenous (IV) titration or IV continuous perfusion, but until now, there is no clear recommendation concerning the superiority of this root over other administration techniques such as nebulization.

In this study we aimed to investigate the efficiency, the feasibility and the tolerance of three morphine administration roots in patients with acute traumatic pain and to clarify the most adequate one to apply in emergency department settings.

Enrollment: 300 patients

Sex: All

Ages: 8 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients older than 8 years and less than 50 years
• patients who consult emergency department for sever pain after an immediately trauma

Exclusion criteria

• Glasgow coma scale <14
• inability to cooperate
• hypotension with systolic blood pressure< 90mmhg
• bradypnea<12cpm
• SAO2<90%
• polytrauma
• nasal trauma
• rhinitis
• nasal obstruction
• allergy to opioids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups, including a placebo group

IV titrated morphine

Placebo Comparator group

Description:

patient will receive 2 mg morphine each 5 min, associated to continuous nebulisation of saline serum (placebo). Morphine administration is stopped when VAS becomes under 50% and treatment failure is defined as VAS \> 50%, 30 minutes after the beginning of the protocol.

Treatment:

Drug: IV titrated morphine

Low dose nebulised morphine

Experimental group

Description:

patient will receive 10 mg of morphine prepared with 4 ml saline serum (SS) and nebulised with 6 l/min flow during 10 minutes. Nebulisation will be repeated 3 times, in addition, patients receive 2 ml IV SS every 5 minutes as placebo

Treatment:

Drug: Low dose nebulised morphine

High dose nebulised morphine

Experimental group

Description:

patient will receive 20 mg of morphine prepared with 3 ml saline serum (SS) and nebulised with 6 l/min flow during 10 minutes. Nebulisation will be repeated 3 times, in addition, patients receive 2 ml IV SS every 5 minutes as placebo.

Treatment:

Drug: High dose nebulised morphine